JP2004500182A - Materials and methods for improved bone-tendon-bone grafts - Google Patents

Materials and methods for improved bone-tendon-bone grafts Download PDF

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JP2004500182A
JP2004500182A JP2001551423A JP2001551423A JP2004500182A JP 2004500182 A JP2004500182 A JP 2004500182A JP 2001551423 A JP2001551423 A JP 2001551423A JP 2001551423 A JP2001551423 A JP 2001551423A JP 2004500182 A JP2004500182 A JP 2004500182A
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bone
tendon
graft
blocks
block
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カーター ケビン シー.
エシュ マイケル
ラローチェル ポール
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リジェネレーション テクノロジーズ インク.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1635Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for grafts, harvesting or transplants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1637Hollow drills or saws producing a curved cut, e.g. cylindrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1675Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the knee
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/007Auxiliary appliance with irrigation system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0847Mode of fixation of anchor to tendon or ligament
    • A61F2002/0858Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0847Mode of fixation of anchor to tendon or ligament
    • A61F2002/087Anchor integrated into tendons, e.g. bone blocks, integrated rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0876Position of anchor in respect to the bone
    • A61F2002/0882Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2835Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • A61F2002/2839Bone plugs or bone graft dowels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4644Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • A61F2002/4649Bone graft or bone dowel harvest sites
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00359Bone or bony tissue

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Dentistry (AREA)
  • Vascular Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Cardiology (AREA)
  • Rheumatology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)
  • Outer Garments And Coats (AREA)

Abstract

Disclosed herein is an improved Bone Tendon Bone graft for use in orthopedic surgical procedures. Specifically exemplified herein is a Bone Tendon Bone graft comprising one or more bone blocks having a groove cut into the surface thereof, wherein said groove is sufficient to accommodate a fixation screw. Also disclosed is a method of harvesting grafts that has improved efficiency and increases the quantity of extracted tissue and minimizes time required by surgeon for implantation.

Description

【0001】
発明の背景
整形外科医学では、骨/腱/骨移植片を前十字靱帯(ACL)または後十字靭帯(PCL)断裂などの頻度の高い関節損傷の修復に用いることに大きな可能性と利点があることが認識されつつある。これらの種類の損傷を修復するために現在用いられている手法の一つでは、損傷靱帯の断裂部分を外科的につなぎ直す。しかし、この手法は、特に靱帯の損傷が広範囲にわたる場合には不可能なことがしばしばである。関節靱帯の損傷が高度な状況に対処するには、損傷した膝に対する支持が強化されるように腱を再配置する別の手法が一般に行われる。これらの従来の手法には欠点があり、ほとんどの症例では、修復された関節は柔軟性および安定性に乏しい。
【0002】
骨/腱移植片が最近利用されるようになって、重症外傷の症例における関節修復の成績は劇的に改善された。関節靱帯の広範損傷の症例でも、整形外科医はドナーの骨/腱移植片を用いて100%の可動域および安定性を実現することができる。
【0003】
このような利点が認識されているものの、骨/腱移植片の利用にはいくつか問題がある。例えば、これらの移植片の移植および固定を伴う外科的処置には長い時間がかかることがある。現在は、手術時に骨/腱/骨移植片の形状をレシピエントに合わせる必要があり、これには30分から1時間以上もの時間を要することがある。さらに、外科医は移植片を取り付けるための手段を設置する必要があり、これにもかなりの手術時間がかかる。
【0004】
骨/腱移植片の使用に伴うもう一つの問題は、供給が限られていることである。この結果、単に組織が入手できないという理由で患者が質の劣る処置を選択しなければならないことが起こりうる。このため、当技術分野には、この問題や上記の問題に対処するシステムに対する需要が存在する。
【0005】
発明の概要
本発明は、関節内の靱帯を再構成するためのより簡単かつより効率的な手術を容易にする新規な骨−腱−骨移植片(BTB)に関する。本発明の1つの局面は、骨ブロックがレシピエント骨の内部に均一かつ一定に配置されるようにあらかじめ成形されている、1つの腱および腱の両端に位置する2つの骨ブロックを含むBTBに関する。
【0006】
1つの特定の局面において、本発明は、1つまたは複数の骨ブロックが切削されて固定ねじを収容するのに充分な溝が提供される、1つまたは複数の骨ブロックおよび前記1つまたは複数の骨ブロックと結合した腱を含み、整形外科手術において有用な骨−腱−骨移植片に関する。または、本発明は、1つまたは複数の骨ブロックおよび前記1つまたは複数の骨ブロックと結合した腱を含み、前記1つまたは複数の骨ブロックがダボ(dowel)としてあらかじめ成形されている、整形外科手術において有用な骨−腱−骨移植片に関する。
【0007】
本発明のさらなる局面は、腱または靱帯が結合した第1の骨栓を切り出す段階;および腱または靱帯が結合した第2の骨栓を切り出す段階を含む、前記第1の骨栓および前記第2の骨栓が連続した骨ストック(bone stock)に由来し、かつ前記第1の骨栓または前記第2の骨栓の切り出しによって後に切り出される方の骨栓に溝が形成されるように重複しているような、複数の骨−腱−骨移植片を入手する方法に関する。
【0008】
さらにもう1つの局面において、本発明は、1つまたは複数の骨ブロックの少なくとも1つが固定ねじを収容するのに適した溝を有する、2つの末端を有する腱または靱帯および前記腱または靱帯と結合した1つまたは複数の骨ブロックを含む、骨−腱−骨移植片を入手する段階を含む、ヒトまたは動物に対して整形外科手術を行う方法に関する。
【0009】
本発明の1つの代替的な局面は、骨ブロックが固定ねじを収容するための溝を含む、1つの骨ブロックおよび1つの腱を含むインプラントに関する。
【0010】
本発明のさらにもう1つの局面は、本発明の原理に従ったBTB移植片を採取するためのBTBコアカッター(core cutter)に関する。
【0011】
本発明の上記およびその他の有利な局面を、以下にさらに詳細に述べる。
【0012】
発明の詳細な開示
図1を参照すると、各々の骨ブロックがダボとしてあらかじめ成形されている、腱130によって相互に連結された第1の骨ブロック110および第2の骨ブロック120を含むBTB 100を対象とする態様が示されている。本明細書で用いる「腱」という用語は、広義の意味で用いることを意図しており、腱、靱帯および脱灰骨などを含むがこれらに限定されない、移植片において用いるための線維性結合組織を指す。本明細書で用いる「BTB」または「骨−腱−骨移植片」という用語は、1つまたは複数の腱部分および1つまたは複数の骨部分を含む移植用インプラント(graft implant)のことを指す。BTBはドナーの膝から単離されていることが好ましい。しかし当業者は、本明細書の教示に鑑みて、好ましさの程度は落ちるものの、これらに限定されないがアキレス腱/踵骨領域または肩領域など身体の他の領域が、本発明によるBTBを回収するために適していることを容易に理解すると考えられる。ドナーから回収した天然の腱または靱帯に由来する腱部分を有するBTBに加えて、これらに限定されないが分節状脱灰骨(segmentally demineralized bone)(国際公開公報第99/21515号)など、その他の適切なインプラントの例も、当業者は直ちに理解すると考えられる。1つのより好ましい態様において、骨ブロックの一方が膝蓋骨に由来し、もう一方が脛骨末端に由来し、腱が膝蓋腱に由来する。
【0013】
固定ねじの配置を容易にするために、ダボには骨ブロックの全長にわたって機械加工を行って半円状の切れ目115、125を形成することが好ましい。半円状の切れ目115、125は、固定ねじを配置するための溝を提供し、この結果、骨ブロックとねじとの間の接触表面積が大きくなるため、移植片とレシピエント骨との結合に役立つ。半円状の切れ目115、125は、孔内の「死んだ」空隙を充填するという利点ともに、骨ブロックの引き抜き荷重(pull out loads)を増加させるという別の利点も提供する。
【0014】
ステープル、ボタン、ねじおよびワッシャー、締り嵌めねじ、およびセルフタッピン(self−tapping)ねじを含むがこれらに限定されない、当技術分野で公知の固定法を、本発明の原理に従って用いることができる。1つの好ましい態様では、締り嵌めねじおよび/またはセルフタッピンねじによって固定を達成する。さらにより好ましい1つの態様において、半円状の切れ目115、125は、固定ねじのねじ山状断面(thread profile)と一致するねじ山状断面135を含み、それによって固定の安定性がさらに高まる。
【0015】
図2を参照すると、本発明のBTBの3つの異なる態様が示されている。図2Aは、本発明のBTBの基本形態を含む態様を示す。骨ブロック210および220は溝のないあらかじめ成形されたダボの形状であり、腱100によって連結されている。図2Bは、両端が先細になったダボとして骨ブロックがあらかじめ成形されている、BTBの別のバージョンを示す。骨ブロック212は腱200からみて近位部に先細の領域216があるダボであり、骨ブロック214は腱200からみて遠位部に先細の領域218があるダボとしてあらかじめ成形されている。図2Cは、近位部に先細の領域239がある骨ブロック230、および骨ブロック230に配置された溝238を有する、本発明の好ましいバージョンを例示したものである。またこのバージョンは、遠位部に先細の領域がある第2の骨ブロック234、および骨ブロック234に配置された溝236も同様に含む。図2B〜図Cに示した態様は、レシピエント骨にあらかじめ形成された孔への移植が矢印の向きに起こることが好ましいように先細になっている(図4も参照)。
【0016】
図3を参照すると、3つの別々の移植片335、345および355が採取されたドナー領域300が図示されている。図に示す通り、3つの異なる移植片はそれぞれ少なくとも1つの骨ブロック330、340および350を有する。移植片を採取する順序は重要ではないが、移植片335を最初に切り出し、続いて外側の移植片345、355を切り出すことが好ましい。移植片335を最初に切り出すことによって他のドナー領域に自動的に切れ目が入り、それによって切り出した際に他の移植片の骨ブロック340、350に溝が作製されるる。1つの好ましい態様において、ドナー領域は脛骨の最上部にある膝蓋腱320の付着部に位置する。1つのさらに好ましい態様において、ドナー領域は膝蓋腱の範囲を越えて膝蓋骨まで至り、骨ブロックは膝蓋骨から切り出される。
【0017】
骨ブロックを、コアカッターおよび穿孔器などの、当技術分野でルーチンに用いられる一般的な器具および手順を用いて摘出できる。1つの好ましい態様では、BTB骨カッターを以下でさらに述べる教示に従って用いることによって骨ブロックを摘出することができる。
【0018】
摘出された骨ブロック330、340および350は一般に栓またはダボへと成形され、好ましくはさらに当技術分野で知られた通常の方法によって機械加工される。1つの特定の態様では、ダボを機械加工して種々の外科的処置に適した寸法にする。機械加工は目盛り付きダイ(graduated die)、研削砥石、旋盤で行うことが好ましく、または本明細書の教示に鑑みて機械加工用の器具をこの目的のために特に設計および適合化させてもよい。ダボの好ましい寸法には直径8mm、9mm、10mm、11mmおよび12mmが含まれる。製造物の寸法の再現性は、このような移植片の臨床環境での使用を成功させるための重要な特徴である。
【0019】
1つの特定の態様において、本発明は、BTBの移植を含む膝十字靱帯損傷の修復法を目的とする。図4はこの手順を例示したものであり、腱433によって連結された2つの骨ブロック432および434を含むBTB 430を収容するための孔466および462がそれぞれの内部に形成された大腿骨400および脛骨410が示されている。孔462を介したBTB 430の誘導を補助するために、縫合糸460を骨ブロック432に選択的に結びつけるが、これによって外科医は孔462を介してBTB 430を引っ張り、その後に縫合糸460を除去することができる。BTB 430が孔462および466の中に正しく配置されたら、締り嵌めねじ440によってBTB 430をレシピエント骨の中に固定する。締り嵌めねじ440はセルフタッピン式であることが好ましく、それぞれ溝438および436と孔466および462との間の空間に回転によって取り付けられる。1つのさらにより好ましい態様では、BTBに位置合わせのための印をあらかじめ付けておくことができる。外科医がBTBを収容するために形成された孔内のBTBの深さを視認し、かつ骨靱帯接合部およびBTBの回転を視認するのに役立つように、このような印をBTBに配置することができる。
【0020】
図5〜図7を参照すると、第1の末端503および第2の末端505を有する軸502を含むコアカッター500などのBTB採取装置を対象とする、本発明のもう1つの態様が示されている。軸502の第1の末端503には、好ましくは、電気ドリル(例えば、Dupuy)に装着したヤコブチャック(Jacob’s chuck)の挿入などによってドリルを入れるために設計された、空洞501が長軸方向に配置されている。軸502の第2の末端505を、中空円筒504の第1の末端512に取り付けることができる。円筒504の第2の末端514は、それに配置された歯510を有することが好ましい。1つの好ましい態様において、円筒には、切除した移植片組織をコアカッター500から除去するのに役立つ少なくとも1つの長穴506が表面に配置されている。また長穴506は、摘出手順の際に移植片を洗浄し、それによって移植片の摩擦焼けが起こる機会を減らす手段も提供する。1つの好ましい態様において、軸502の長さは約90mmであり、円筒504の長さは約50mmであり、長穴506の長さは約30mmである。1つのさらにより好ましい態様において、中空円筒512の第1の末端には、軸502に向かって角度を付けて面取りした部分522がある。
【0021】
図6には、コアカッター歯510の拡大図を例示す。歯Aの半径および歯Bのすくい角(下端角(bottom angle)とも呼ぶ)は、歯の故障(例えば、屈曲または破断)および移植片への望ましくない損傷が避けられるような適切な値であることが好ましい。例えば、図6Aには許容されない歯パターンが示されており、半径Aおよび下端角Bが大きすぎるため、歯に対する支持が不十分な構造となり故障が不可避である。本発明によれば、直径が約10mm〜11mmのコアカッターは約14個の歯を有することが好ましく、歯の半径Aは約20mm〜30mm(25mmがより好ましい)であり下端角Bは約10度〜20度(15度がより好ましい)である。より小さいまたは大きい骨ブロック用に設計するコアカッターについては、前記の寸法を保ちながら、歯の数を適宜減少または増加させることが好ましい。1つの好ましい態様では、円筒の直径が10mm〜11mmから1mm減少または増加するごとに歯の数を2個ずつそれぞれ減少させまたは増加させる。例えば、円筒の直径が12mmのコアカッターは約16個の歯を有することが好ましいと考えられる。
【0022】
図7には、円筒504の末端部(図5に示した円形部分)の拡大図を示しており、円筒504の内面に逃げ厚さ(relief thickness)520を加えることによって内径(ID)がわずかに減少する、円筒504の好ましい態様が図示されている。この態様は、望ましいパラメーターの範囲内にある摘出された骨ブロックを選択するためのサイズ計測装置(例えば、リング)を用いた場合に更なる便利さを提供する。例えば、10mmのサイズ計測装置によるBTBの選択では、計測装置よりもわずかに小さい直径を有するBTBが必要であることが好ましいと考えられ、BTBの形状にそれ以外のどんな小さな不規則性がっても計測装置を通過できない。逃げ厚さ520によって円筒504のIDが減少し、それによってBTBに対するこのわずかな修正が実現される。
【0023】
図8には、膝手術時の移植に特に適合化された本発明のBTBのさらなる態様800が示されており、ここでBTBの移植および固定は二方向性である。BTB態様800は1つの骨ブロック部分810および1つの腱部分820を有する。態様800を採取するのに好ましい領域は踵、腿または肩であると思われる。より好ましくは、態様800を踵または腿から採取し、それにより腱部分820はドナーのアキレス腱または四頭筋腱に由来する。骨ブロック部分810は、先細の領域816および818をそれぞれ含む2つの末端812および814を有する。2つの先細領域812および814の存在により、BTB態様800の挿入および固定を二方向性に行うことが可能となり、このことは例えば、図4に示した方法に関連した上記の脛骨462または大腿骨466のいずれかの孔への移植を意味する。当然ながら、移植部位には上方の進入点からのアプローチが可能である、すなわち、脛骨とは反対に大腿骨に貫通孔を設置する。BTB態様800はこのような二者択一的な処置においていずれの孔に固定するにも適すると考えられる。さらに、インプラントの固定を補助するために、溝850を有する骨ブロック810を提供することもできる。加えて、移植時には縫合糸または移植片挿入器具などによるインプラントの操作のための手段があることが望ましいと考えられる。したがって、BTB態様800は、縫合糸および/または移植片挿入器具を収容するため、あらかじめ形成された移植片操作穴852および854と共に提供される。移植片操作穴の向きの例示において、移植片操作穴852および854はそれぞれ骨ブロック810の軸に対して直角または平行であることが示されている。あらかじめ形成された移植片操作穴は穿孔などの従来の方法によって作成可能である。あらかじめ形成された穴852および854への挿入に適した器具を当業者は容易に認識すると考えられる。好ましくは、用いる移植片挿入器具は、移植片操作穴への挿入に適した形状およびサイズを有する末端を含む。
【0024】
当業者は、移植片が自家移植片、同種移植片または異種移植片でありうることを理解すると考えられる。異種移植片インプラントにはさらに、移植片に存在する抗原性物質および/または潜在的病原性物質のレベルを最小限に抑えるための処理が必要でありうる。レシピエントに適していてかつ拒絶されないように組織を調製するための現時点で知られている技法または後に開発される技法は、本明細書に組み入れられる。移植片が同種移植片または異種移植片である場合には、ヒト免疫不全ウイルス、サイトメガロウイルス、B型肝炎、C型肝炎および他のいくつかの病原体を含む、種々の伝染性の疾患および病原体についてドナーのスクリーニングを行うことが好ましい。これらの検査は、ELISAアッセイ法、PCRアッセイ法または血球凝集試験を含むがこれらに限定されない、当技術分野における多くの一般的な手段の任意のものによって行われうる。このような検査は以下の団体の要求基準に従う:(a)米国組織バンク学会(American Assocation of Tissue Banks)、「組織バンクのための技術マニュアル、技術マニュアル−骨格筋組織(Technical Manual for Tissue Banking、Technical Manual−Musculoskeletal Tissues)」、M19ページ〜M20ページ;(b)米国食品医薬品局(The Food and Drug Administration)、「暫定規則(Interim Rule)」、「連邦官報(Federal Register)」、Vol. 58、No. 238、Tuesday、December 14、「規則(Rules and Regulations)」65517,D.、「感染症検査およびドナーのスクリーニング( Infectious Disease Testing and Donor Screening)」;(c)MMWR、Vol.43、No. RR−8、「ヒトの組織および臓器の移植によるヒト免疫不全ウイルスの感染防止のための指針(Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs)」、4ページ〜7ページ;(d)Florida Administrative Weekly、Vol. 10、No.34、August 21、1992、59A−1.001−014、59A−1.005(12)(c)、F.A.C.,(12)(a)−(h)、59A−1.005(15、F.A.C.,(4)(a)−(8)。一連の標準的な生化学的アッセイに加えて、ドナーまたはその近親者に対して、ドナーが、多数の性交渉相手がいる、血友病に罹患している、静脈用薬剤を使用しているといったハイリスクの行為に該当するか否かを確認するための問診を行うこともできる。ドナーが許容されうると確認されれば、上記のBTBを得るための組織を採取して洗浄する。
【0025】
本明細書の全体を通じて引用したすべての特許および刊行物の開示内容は、それが本明細書の開示と矛盾しない範囲内で、その全体が参照として組み入れられる。
【0026】
本明細書に記載した実施例および態様は例示のみを目的としたものであり、当業者にはそれらに鑑みて種々の修正または変更が連想されると考えられるが、それらも本出願の精神および範囲ならびに添付の特許請求の範囲の範囲内に含まれることが理解されねばならない。
【0027】
実施例 :膝蓋腱・脛骨ドナーに対する粗 BTB の採取のための手順
BTBを以下の手順に従って採取した:
【0028】
1. 鈍的および鋭的切開を用いて腱の前部から3層の結合組織を摘出する。
【0029】
2. メスまたはハサミを用いて腱の内側および外側の境界に沿って切断する。腱を脂肪層から分離するためにハサミを用いて鈍的切開を行う。
【0030】
3. 膝蓋ブロックの周囲を切断し、それを近位の脛骨および遠位の大腿骨から分離する。必要に応じて膝蓋に約4cmの四頭筋腱が結合したままにする。四頭筋腱を結合させない場合には鋭的切開によって四頭筋を膝蓋から完全に切り離す。
【0031】
4. 腱を被膜(capsule)から引き出し、脛骨挿入点に対するすべての余剰な脂肪組織を除去する。
【0032】
5. 腱挿入点から約30mmの脛骨粗面に鋸を用いて横向きの切れ目を入れる。挿入点の近位部約5mmにも同様の切れ目を入れて、脛骨プラトー部を除去する。
【0033】
6. 腱が付いていても、鋸を用いて脛骨ブロックを切削して面をそろえる。
【0034】
7. 鋸を用いて、膝蓋骨ブロックの三方を切削して面をそろえる(四頭筋腱がまだ付着している場合には内側および外側のみを四角にする)。
【0035】
8. 無関係な軟組織および軟骨を膝蓋骨、脛骨粗面および腱から除去する。
【0036】
9. 膝蓋腱を二等分するために、メスを用いて腱を内側および外側の半分に分ける。各半分は別に特記しない限り14mmまたはそれ以上が必要である。
【0037】
10. 腱の分割に用いたのと同じ内側/外側線に従って、鋸を用いて膝蓋骨ブロックおよび脛骨ブロックを半分に分割する。
【0038】
11. 骨ブロックを滅菌水または生理食塩水で十分に洗浄する。
【0039】
実施例 :膝蓋腱・脛骨ドナーに対する、あらかじめ成形されたダボを備えた膝蓋腱を形成するための手順
BTBを以下の手順に従って採取した:
【0040】
1. 鈍的および鋭的切開を用いて腱の前部から3層の結合組織を摘出する。
【0041】
2. メスまたはハサミを用いて腱の内側および外側の境界に沿って切断する。腱を脂肪層から分離するためにハサミを用いて鈍的切開を行う。
【0042】
3. 膝蓋ブロックの周囲を切断し、それを近位の脛骨および遠位の大腿骨から分離する。
【0043】
4. 腱を被膜から引き出し、脛骨挿入点に対するすべての余剰な脂肪組織を除去する。
【0044】
5. 腱挿入点から約30mmの脛骨粗面に鋸を用いて横向きの切れ目を入れる。挿入点のすぐ近位部にも同様の切れ目を入れて脛骨プラトー部を除去する。挿入点の後方20〜30mmの冠状面にも別の切れ目を入れる。
【0045】
6. 鋸を用いて脛骨ブロックの面をそろえる。
【0046】
7. 鋸を用いて膝蓋骨ブロックの三方を切削して面をそろえる。
【0047】
8. 手術台上面にバイス(vice)を取り付ける。バイスに脛骨ブロックを入れ、近位面および遠位面に沿って保持する。骨ブロックの遠位面は加工機に面しており、そこから腱が出るようにする。骨を破砕しない範囲でバイスをしっかりと締める。
【0048】
9. ドリルにヤコブチャック(Jacob’s chuck) を装着し、適切な大きさのカッターを挿入する。チャックキーでチャックを締める。注:各骨ブロックから少なくとも2つの栓を切り出すようにする。
【0049】
10. カッターを骨ブロックに対して配置し、カッターの歯が腱に当たらずに腱のすぐ上をかすめるようにする。骨栓の全長にわたって最大の接触が得られるようにカッターを配置する。
【0050】
11. ドリルのスイッチを入れ、栓の穿孔を始める。カッターが栓の末端に近づいたら、カッターが骨ブロックの近位端を通過するまでドリルの回転を遅くする。腱を傷つけないようにカッターおよびドリルから栓を採取する。
【0051】
12. 第2の栓に対して段階10および11を繰り返す。
【0052】
13. ハサミまたはメスを用いて腱を内側および外側の半分に分割する。
【0053】
14. 手術台のバイスから余剰な骨を除去し、膝蓋骨ブロックをバイスに入れ、ブロックの近位面および遠位面に沿って保持する。骨ブロックの近位面は加工機に面しており、そこから腱が出るようにする。骨を破砕しない範囲でバイスをしっかりと締める。
【0054】
15. 両方の栓に対して段階10および11を繰り返す。
【0055】
16. 栓が完成したところで余剰な膝蓋骨をバイスから除去し、バイスを手術台から外す。
【0056】
17. カッターをヤコブチャックから外し、1.5mmのドリルビットをチャックに装着する。チャックキーを締める。
【0057】
18. 鋸を用いて各々の栓を長さ約30mmに切断する(25mm未満にはしない)。
【0058】
19. アルトレックスクランプを用いて栓をその中に配置し、栓の末端をクランプの末端と同一面にする。栓を前/後に配置する。そろえた栓の末端に最も近い第1のガイド穴を用い、1.5mmのドリルビットを用いて栓に穿孔する。栓を180度回転させて内側/外側になるように配置する。第2のガイド穴を用いて、そろえた栓の末端から栓を貫通する第2の穴を開ける。
【0059】
20. すべての骨栓に対して段階19を繰り返す。
【0060】
21. サイズ計測装置を用いて各骨栓を適切なサイズのゲージに通す。BTB全体が容易に通り抜ける必要がある。必要に応じてトリミングを行う。
【0061】
22. 骨栓を滅菌水または生理食塩水で十分に洗浄する。
【図面の簡単な説明】
【図1】ねじ山状の断面をもつ溝を有するBTBの態様を示す。
【図2】本発明によるBTBの3つの異なる態様の側面図を示す。
【図3】本明細書の教示によるBTBを採取するためのドナー領域の正面図を示す。
【図4】本明細書の教示によるBTBの移植による損傷領域の再構成を例示した本発明のもう1つの態様を示す。
【図5】BTB移植片を採取するために設計された本発明のBTBコアカッターの側面図を示す。
【図6】図6Aは、本発明による使用に関して望ましさの程度が低い(less desired)歯の形態の拡大図を示す。図6Bは、図5に示した態様の歯の好ましい態様の拡大図を示す。
【図7】図5に示した円形領域を引き伸ばした図である。
【図8】両端が先細になった1つのブロックを含む本発明のBTBのさらなる態様の三次元的側面図である。
[0001]
Background of the Invention
Orthopedic medicine recognizes the great potential and benefits of using bone / tendon / bone grafts to repair frequent joint injuries, such as anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) tears. Is being done. One technique currently used to repair these types of injuries involves surgically reattaching the rupture of the injured ligament. However, this technique is often not possible, especially when ligament damage is extensive. To address the situation where joint ligament damage is high, another approach to repositioning tendons so that support for the damaged knee is enhanced is commonly performed. These conventional approaches have drawbacks, and in most cases, the repaired joint is less flexible and stable.
[0002]
With the recent availability of bone / tendon grafts, the performance of joint repair in severe trauma cases has improved dramatically. Even in cases of extensive joint ligament injury, orthopedic surgeons can achieve 100% range of motion and stability with donor bone / tendon grafts.
[0003]
Despite these benefits being recognized, there are several problems with using bone / tendon grafts. For example, surgical procedures involving the implantation and fixation of these implants can take a long time. Currently, bone / tendon / bone graft shapes must be tailored to the recipient at the time of surgery, which can take from 30 minutes to an hour or more. In addition, the surgeon must provide a means for attaching the implant, which also requires significant operating time.
[0004]
Another problem with the use of bone / tendon grafts is the limited supply. This can result in the patient having to choose a poor quality treatment simply because tissue is not available. Thus, there is a need in the art for a system that addresses this and the above problems.
[0005]
Summary of the Invention
The present invention relates to a novel bone-tendon-bone graft (BTB) that facilitates simpler and more efficient surgery for reconstructing ligaments in a joint. One aspect of the present invention relates to a BTB comprising one tendon and two bone blocks located at both ends of the tendon, wherein the bone block is pre-shaped so that it is uniformly and uniformly disposed within the recipient bone. .
[0006]
In one particular aspect, the invention relates to one or more bone blocks and the one or more bone blocks, wherein one or more bone blocks are cut to provide sufficient grooves to accommodate fixation screws. A bone-tendon-bone graft useful in orthopedic surgery, comprising a tendon associated with a bone block of the same. Alternatively, the present invention provides an orthopedic device that includes one or more bone blocks and a tendon associated with the one or more bone blocks, wherein the one or more bone blocks are pre-shaped as a dowel. Bone-tendon-bone grafts useful in surgery.
[0007]
A further aspect of the invention includes cutting out the first bone plug with attached tendon or ligament; and cutting out the second bone plug with attached tendon or ligament. Are derived from a continuous bone stock and overlap such that a groove is formed in the bone plug that is subsequently cut by the cutting of the first or second bone plug. And obtaining a plurality of bone-tendon-bone grafts as described above.
[0008]
In yet another aspect, the present invention relates to a two-ended tendon or ligament having at least one of one or more bone blocks having a groove adapted to receive a fixation screw and coupled to the tendon or ligament A method of performing orthopedic surgery on a human or animal, comprising obtaining a bone-tendon-bone graft comprising one or more bone blocks obtained.
[0009]
One alternative aspect of the invention relates to an implant comprising one bone block and one tendon, wherein the bone block includes a groove for receiving a fixation screw.
[0010]
Yet another aspect of the present invention relates to a BTB core cutter for harvesting a BTB graft in accordance with the principles of the present invention.
[0011]
These and other advantageous aspects of the invention are described in further detail below.
[0012]
Detailed Disclosure of the Invention
Referring to FIG. 1, an embodiment directed to a BTB 100 that includes a first bone block 110 and a second bone block 120 interconnected by tendons 130, each bone block being pre-shaped as a dowel. It is shown. The term "tendon" as used herein is intended to be used in a broad sense and includes fibrous connective tissue for use in implants, including but not limited to tendons, ligaments and demineralized bone Point to. The term "BTB" or "bone-tendon-bone graft" as used herein refers to a graft implant that includes one or more tendon portions and one or more bone portions. . Preferably, the BTB has been isolated from the knee of the donor. However, one of ordinary skill in the art will appreciate that other areas of the body, such as, but not limited to, the Achilles tendon / calcaneal region or the shoulder region, may recover BTB according to the present invention in light of the teachings herein. It would be easy to understand that it is suitable for In addition to BTB having tendons derived from natural tendons or ligaments collected from donors, other such as, but not limited to, segmentally demineralized bone (WO 99/21515) Examples of suitable implants will also be readily apparent to those skilled in the art. In one more preferred embodiment, one of the bone blocks is from the patella, the other is from the distal tibia, and the tendon is from the patella tendon.
[0013]
Preferably, the dowels are machined over the entire length of the bone block to form semicircular cuts 115, 125 to facilitate placement of the fixation screws. The semi-circular cuts 115, 125 provide grooves for placement of the fixation screws, resulting in a larger contact surface area between the bone block and the screws, thus providing a better connection between the implant and the recipient bone. Useful. The semi-circular cuts 115, 125 provide the advantage of filling the "dead" voids in the holes, as well as the additional benefit of increasing the pull out loads of the bone block.
[0014]
Any fastening method known in the art, including but not limited to staples, buttons, screws and washers, interference-fitting screws, and self-tapping screws, can be used in accordance with the principles of the present invention. In one preferred embodiment, the fixation is achieved by interference and / or self-tapping screws. In one even more preferred embodiment, the semi-circular cuts 115, 125 include a threaded section 135 that matches the thread profile of the fixing screw, thereby further increasing the stability of the fixation.
[0015]
Referring to FIG. 2, three different aspects of the BTB of the present invention are shown. FIG. 2A shows an embodiment including the basic embodiment of the BTB of the present invention. Bone blocks 210 and 220 are in the form of a grooveless preformed dowel and are connected by tendon 100. FIG. 2B shows another version of the BTB in which the bone block is preformed as a dowel with tapered ends. Bone block 212 is a dowel with a tapered region 216 proximal to tendon 200, and bone block 214 is preformed as a dowel with a tapered region 218 distal to tendon 200. FIG. 2C illustrates a preferred version of the present invention having a bone block 230 with a tapered region 239 proximally and a groove 238 located in the bone block 230. This version also includes a second bone block 234 with a tapered region at the distal portion, and a groove 236 located in the bone block 234. The embodiment shown in FIGS. 2B-C is tapered such that implantation into a preformed hole in the recipient bone preferably occurs in the direction of the arrow (see also FIG. 4).
[0016]
Referring to FIG. 3, there is illustrated a donor region 300 from which three separate grafts 335, 345 and 355 have been harvested. As shown, the three different implants each have at least one bone block 330, 340 and 350. The order in which the grafts are harvested is not critical, but it is preferable to cut the graft 335 first, followed by the outer grafts 345, 355. The first cut of the graft 335 automatically cuts other donor regions, thereby creating grooves in the other graft bone blocks 340, 350 when cut. In one preferred embodiment, the donor region is located at the attachment of the patella tendon 320 at the top of the tibia. In one more preferred embodiment, the donor region extends beyond the patella tendon to the patella, and the bone block is cut from the patella.
[0017]
Bone blocks can be removed using common instruments and procedures routinely used in the art, such as core cutters and perforators. In one preferred embodiment, a bone block can be removed using a BTB bone cutter according to the teachings further described below.
[0018]
The removed bone blocks 330, 340 and 350 are generally formed into stoppers or dowels, and are preferably further machined by conventional methods known in the art. In one particular aspect, the dowel is machined to dimensions suitable for various surgical procedures. Machining is preferably performed on a graded die, grinding wheel, lathe, or in view of the teachings herein, the instrument for machining may be specifically designed and adapted for this purpose. . Preferred dimensions of the dowel include 8 mm, 9 mm, 10 mm, 11 mm and 12 mm in diameter. Product dimensional reproducibility is an important feature for the successful use of such implants in a clinical setting.
[0019]
In one particular aspect, the present invention is directed to a method of repairing a cruciate ligament injury including implantation of BTB. FIG. 4 illustrates this procedure, wherein holes 466 and 462 for receiving a BTB 430 including two bone blocks 432 and 434 connected by a tendon 433 are formed therein, respectively. The tibia 410 is shown. Suture 460 is selectively tied to bone block 432 to assist in guiding BTB 430 through hole 462, thereby allowing the surgeon to pull BTB 430 through hole 462 and subsequently remove suture 460. can do. Once BTB 430 is properly positioned in holes 462 and 466, BTB 430 is secured into recipient bone by interference screw 440. The interference screw 440 is preferably self-tapping and is rotationally mounted in the space between the grooves 438 and 436 and the holes 466 and 462, respectively. In one even more preferred embodiment, the BTB can be pre-marked for alignment. Placing such indicia on the BTB to assist the surgeon in viewing the depth of the BTB in the hole formed to accommodate the BTB and in viewing the rotation of the bone ligament junction and the BTB. Can be.
[0020]
Referring to FIGS. 5-7, another aspect of the present invention is shown directed to a BTB harvesting device, such as a core cutter 500, including a shaft 502 having a first end 503 and a second end 505. I have. The first end 503 of the shaft 502 preferably has a long axis 501 designed for drilling, such as by inserting a Jacob's chuck attached to an electric drill (eg, Dupuy). It is arranged in the direction. A second end 505 of the shaft 502 can be attached to a first end 512 of the hollow cylinder 504. The second end 514 of the cylinder 504 preferably has teeth 510 disposed thereon. In one preferred embodiment, the cylinder has at least one slot 506 on its surface that helps to remove the resected graft tissue from the core cutter 500. Slot 506 also provides a means of cleaning the implant during the extraction procedure, thereby reducing the chance of friction burning of the implant. In one preferred embodiment, the length of the shaft 502 is about 90 mm, the length of the cylinder 504 is about 50 mm, and the length of the slot 506 is about 30 mm. In one even more preferred embodiment, the first end of hollow cylinder 512 has a portion 522 that is chamfered at an angle toward axis 502.
[0021]
FIG. 6 shows an enlarged view of the core cutter teeth 510 as an example. The radius of tooth A and the rake angle of tooth B (also referred to as bottom angle) are appropriate values to avoid tooth failure (eg, bending or breaking) and unwanted damage to the implant. Is preferred. For example, FIG. 6A shows an unacceptable tooth pattern, where the radius A and the lower end angle B are too large, resulting in an insufficiently supported structure for the teeth, and a failure is inevitable. According to the present invention, a core cutter having a diameter of about 10-11 mm preferably has about 14 teeth, the radius A of the teeth is about 20-30 mm (preferably 25 mm) and the lower end angle B is about 10-10. Degrees to 20 degrees (preferably 15 degrees). For core cutters designed for smaller or larger bone blocks, it is preferable to reduce or increase the number of teeth as appropriate, while maintaining the above dimensions. In one preferred embodiment, each time the diameter of the cylinder decreases or increases by 10 mm to 11 mm by 1 mm, the number of teeth is respectively reduced or increased by two. For example, a core cutter having a cylinder diameter of 12 mm may preferably have about 16 teeth.
[0022]
FIG. 7 shows an enlarged view of the end portion (the circular portion shown in FIG. 5) of the cylinder 504, and the inside diameter (ID) is reduced by adding a relief thickness 520 to the inner surface of the cylinder 504. A preferred embodiment of the cylinder 504 is shown, which reduces to: This aspect provides additional convenience when using a sizing device (eg, a ring) to select an extracted bone block that is within the desired parameters. For example, the selection of a BTB with a 10 mm size measurement device would preferably require a BTB with a slightly smaller diameter than the measurement device, and any other small irregularities in the shape of the BTB would be desirable. Cannot pass through the measuring device. The relief thickness 520 reduces the ID of the cylinder 504, thereby achieving this slight modification to the BTB.
[0023]
FIG. 8 illustrates a further embodiment 800 of the BTB of the present invention that is particularly adapted for implantation during knee surgery, wherein implantation and fixation of the BTB is bidirectional. BTB embodiment 800 has one bone block portion 810 and one tendon portion 820. The preferred area for harvesting embodiment 800 may be the heel, thigh or shoulder. More preferably, embodiment 800 is taken from the heel or thigh, whereby tendon portion 820 is derived from the donor's Achilles or quadriceps tendon. Bone block portion 810 has two ends 812 and 814 that include tapered regions 816 and 818, respectively. The presence of the two tapered regions 812 and 814 allows for bi-directional insertion and fixation of the BTB aspect 800, such as the tibia 462 or femur described above in connection with the method illustrated in FIG. 466 means implantation into any hole. Of course, the implantation site can be approached from the point of entry above, i.e., a through hole is placed in the femur as opposed to the tibia. It is believed that the BTB embodiment 800 is suitable for securing to any hole in such an alternative procedure. Further, a bone block 810 having a groove 850 can be provided to assist in fixation of the implant. In addition, it may be desirable to have a means for manipulating the implant at the time of implantation, such as with sutures or implant insertion tools. Accordingly, BTB aspect 800 is provided with preformed graft manipulation holes 852 and 854 to accommodate sutures and / or graft insertion tools. In the illustration of the orientation of the graft manipulation holes, the graft manipulation holes 852 and 854 are shown to be perpendicular or parallel to the axis of the bone block 810, respectively. Preformed implant manipulation holes can be made by conventional methods such as drilling. Those skilled in the art will readily recognize suitable devices for insertion into preformed holes 852 and 854. Preferably, the implant insertion device used includes a distal end having a shape and size suitable for insertion into a graft manipulation hole.
[0024]
One of skill in the art will appreciate that the graft can be an autograft, an allograft or a xenograft. Xenograft implants may further require treatment to minimize the levels of antigenic and / or potential pathogenic agents present in the graft. Currently known or later developed techniques for preparing tissue suitable and non-rejectable for the recipient are incorporated herein. If the graft is an allograft or a xenograft, various infectious diseases and pathogens, including human immunodeficiency virus, cytomegalovirus, hepatitis B, hepatitis C and some other pathogens It is preferred to screen donors for These tests can be performed by any of a number of common means in the art, including but not limited to ELISA assays, PCR assays or hemagglutination tests. Such testing is in accordance with the requirements of the following organizations: (a) American Association of Tissue Banks, "Technical Manual for Tissue Banks, Technical Manual-Technical Manual for Tissue Banking, Technical Manual-Musculoskeletal Tissues ", pages M19-M20; (b) The United States Food and Drug Administration (The Food and Drug Administration)," Provisional Rules (Interim Rule) "," Federal Register (Federal Register), Federal Register (Federal Register). 58, no. 238, Tuesday, December 14, "Rules and Regulations" 65517, D.C. , "Infectious Disease Testing and Donor Screening"; (c) MMWR, Vol. 43, no. RR-8, "Guidelines for Presenting Transmission of Human Immunodeficiency Virus Throughthrough Translation of Human Tissue; Fourth Page d) Florida Administrative Weekly, Vol. 10, No. 34, August 21, 1992, 59A-1.001-014, 59A-1.005 (12) (c), F.C. A. C. , (12) (a)-(h), 59A-1.005 (15, FAC, (4) (a)-(8), in addition to a series of standard biochemical assays. To the donor or relatives to determine if the donor is a high-risk act, such as having a large number of sexual partners, suffering from hemophilia, or using intravenous drugs. A questionnaire to confirm can also be made, and if the donor is confirmed to be acceptable, the tissue for obtaining the BTB is collected and washed.
[0025]
The disclosures of all patents and publications cited throughout this specification are incorporated by reference in their entirety to the extent that they do not conflict with the disclosure herein.
[0026]
The examples and embodiments described herein are for the purpose of illustration only, and various modifications or changes will be suggested to those skilled in the art in light of the spirit and spirit of the present application. It should be understood that they fall within the scope as well as the scope of the appended claims.
[0027]
Example 1 : Crude for patella tendon / tibia donor BTB For harvesting
BTB was collected according to the following procedure:
[0028]
1.摘 Remove three layers of connective tissue from the front of the tendon using blunt and sharp incisions.
[0029]
2.切断 Use a scalpel or scissors to cut along the medial and lateral boundaries of the tendon. A blunt incision is made with scissors to separate the tendon from the fat layer.
[0030]
3.切断 Cut around the patella block and separate it from the proximal tibia and distal femur. If necessary, leave the patella with a quadriceps tendon attached to it. If the quadriceps tendon is not to be joined, the quadriceps is completely separated from the patella by a sharp incision.
[0031]
4.引 き 出 し Pull the tendon out of the capsule and remove any excess fat tissue for the tibia insertion point.
[0032]
5.横 Make a transverse cut on the rough surface of the tibia about 30 mm from the tendon insertion point using a saw. A similar cut is made about 5 mm proximal to the insertion point to remove the tibial plateau.
[0033]
6.て も Even if there is a tendon, cut the tibial block using a saw and align the surfaces.
[0034]
7.切削 Using a saw, cut three sides of the patella block to align the faces (if the quadriceps tendon is still attached, square only the medial and lateral sides).
[0035]
8.除去 Remove extraneous soft tissue and cartilage from patella, tibial tuberosity and tendon.
[0036]
9. 、 Use a scalpel to divide the tendon into medial and lateral halves to bisect the patella tendon. Each half requires 14 mm or more unless otherwise specified.
[0037]
10.分割 Divide the patella block and tibial block in half using a saw, following the same medial / lateral lines used to split the tendon.
[0038]
11.す る Rinse the bone block thoroughly with sterile water or saline.
[0039]
Example 2 : Procedure for forming a patella tendon with a preformed dowel for patella tendon / tibia donor
BTB was collected according to the following procedure:
[0040]
1.摘 Remove three layers of connective tissue from the front of the tendon using blunt and sharp incisions.
[0041]
2.切断 Use a scalpel or scissors to cut along the medial and lateral boundaries of the tendon. A blunt incision is made with scissors to separate the tendon from the fat layer.
[0042]
3.切断 Cut around the patella block and separate it from the proximal tibia and distal femur.
[0043]
4.引 き 出 し Pull the tendon out of the capsule and remove any excess adipose tissue for the tibia insertion point.
[0044]
5.横 Make a transverse cut on the rough surface of the tibia about 30 mm from the tendon insertion point using a saw. A similar cut is made immediately proximal to the insertion point to remove the tibial plateau. Another cut is made in the coronal plane 20-30 mm behind the insertion point.
[0045]
6. Align the tibial block with a saw.
[0046]
7.切削 Use a saw to cut three sides of the patella block and align the surfaces.
[0047]
8.取 り 付 け る Attach a vice to the top of the operating table. Place the tibial block in the vise and hold along the proximal and distal surfaces. The distal surface of the bone block faces the machine from which the tendons emerge. Tighten the vise as far as the bone will not break.
[0048]
9.装着 Attach a Jacob's chuck to the drill and insert a cutter of an appropriate size. Tighten the chuck with the chuck key. Note: At least two plugs should be cut from each bone block.
[0049]
10.配置 Place the cutter against the bone block so that the teeth of the cutter do not hit the tendon and graze just above the tendon. Position the cutter for maximum contact over the entire length of the bone plug.
[0050]
11.ス イ ッ チ Switch on the drill and start drilling the stopper. When the cutter approaches the end of the plug, slow down the drill until the cutter passes the proximal end of the bone block. Remove the plug from the cutter and drill to avoid damaging the tendon.
[0051]
12.段 階 Repeat steps 10 and 11 for the second stopper.
[0052]
13.腱 Divide the tendon into medial and lateral halves using scissors or a scalpel.
[0053]
14.し Remove excess bone from the operating table vise and place the patella block in the vise and hold along the proximal and distal surfaces of the block. The proximal surface of the bone block faces the processing machine, from which tendons can emerge. Tighten the vise as far as the bone will not break.
[0054]
15.段 階 Repeat steps 10 and 11 for both stoppers.
[0055]
16.と こ ろ で When the stopper is completed, remove the excess patella from the vise and remove the vise from the operating table.
[0056]
17.外 Remove the cutter from the Jacob chuck and attach a 1.5 mm drill bit to the chuck. Tighten the chuck key.
[0057]
18.切断 Use a saw to cut each stopper to a length of about 30 mm (not less than 25 mm).
[0058]
19.用 い Place the stopper therein using the Artrex clamp, flushing the end of the stopper with the end of the clamp. Place stopper before / after. Using the first guide hole closest to the end of the aligned plug, pierce the stopper with a 1.5 mm drill bit. Rotate the plug 180 degrees and place it inside / outside. The second guide hole is used to make a second hole through the stopper from the end of the aligned stopper.
[0059]
20.段 階 Repeat step 19 for all bone plugs.
[0060]
21.通 Pass each bone plug through an appropriate size gauge using a size measuring device. The entire BTB must pass easily. Trim as necessary.
[0061]
22.す る Rinse the bone plug thoroughly with sterile water or saline.
[Brief description of the drawings]
FIG. 1 shows an embodiment of a BTB having a groove having a thread-shaped cross section.
FIG. 2 shows a side view of three different embodiments of a BTB according to the invention.
FIG. 3 shows a front view of a donor region for collecting BTB in accordance with the teachings herein.
FIG. 4 illustrates another aspect of the present invention illustrating the reconstruction of an injured area by implantation of a BTB in accordance with the teachings herein.
FIG. 5 shows a side view of a BTB core cutter of the present invention designed to harvest a BTB implant.
FIG. 6A shows an enlarged view of a less desirable tooth morphology for use in accordance with the present invention. FIG. 6B shows an enlarged view of a preferred embodiment of the tooth of the embodiment shown in FIG.
FIG. 7 is an enlarged view of the circular area shown in FIG. 5;
FIG. 8 is a three-dimensional side view of a further embodiment of the BTB of the present invention including a single tapered block at both ends.

Claims (36)

1つまたは複数の骨ブロックおよび該1つまたは複数の骨ブロックと結合した(attached)腱を含み、該1つまたは複数の骨ブロックがダボ(dowel)として成形されている、整形外科手術において有用な骨−腱−骨(bone tendon bone)移植片(graft)。Useful in orthopedic surgery, comprising one or more bone blocks and tendons attached to the one or more bone blocks, wherein the one or more bone blocks are shaped as dowels Bone-tendon-bone graft. 骨−腱−骨移植片が1つの骨ブロックを含み、該腱がドナーのアキレス腱、膝蓋腱または四頭筋腱に由来する、請求項1記載の骨−腱−骨移植片。2. The bone-tendon-bone graft of claim 1, wherein the bone-tendon-bone graft comprises one bone block, wherein the tendon is derived from a donor's Achilles, patella or quadriceps tendon. 1つの骨ブロックが第1の末端および第2の末端を含み、該第1および第2の末端が先細になっている、請求項2記載の骨−腱−骨移植片。3. The bone-tendon-bone graft of claim 2, wherein one bone block includes a first end and a second end, wherein the first and second ends are tapered. 1つの骨ブロックが、固定ねじを収容するのに充分な溝を含む、請求項2記載の骨−腱−骨移植片。3. The bone-tendon-bone graft of claim 2, wherein one bone block includes a groove sufficient to receive a fixation screw. 1つの骨ブロックが少なくとも1つの移植片操作穴を含む、請求項2記載の骨−腱−骨移植片。3. The bone-tendon-bone graft of claim 2, wherein one bone block includes at least one graft manipulation hole. 1つまたは複数の骨ブロックが切削されて固定ねじを収容するのに充分な溝が提供される、請求項1記載の骨−腱−骨移植片。2. The bone-tendon-bone graft of claim 1, wherein one or more bone blocks are cut to provide sufficient grooves to receive fixation screws. 1つまたは複数の骨ブロックの直径が8mm、9mm、10mm、11mmまたは12mmである、請求項1記載の骨−腱−骨移植片。2. The bone-tendon-bone graft of claim 1, wherein the one or more bone blocks have a diameter of 8 mm, 9 mm, 10 mm, 11 mm or 12 mm. 溝が骨ブロックの全長にわたる半円状の切れ目(radius cut)である、請求項1記載の骨−腱−骨移植片。2. The bone-tendon-bone graft of claim 1, wherein the groove is a radius cut over the entire length of the bone block. 骨ブロックの溝の表面にねじ山状断面(thread profile)を有する、請求項1記載の骨−腱−骨移植片。The bone-tendon-bone graft according to claim 1, wherein the bone-tendon-bone graft has a thread profile on the surface of the groove of the bone block. 腱が第1の末端および第2の末端を有し、1つまたは複数の骨ブロックが、該第1の末端と結合した第1の骨ブロックおよび該第2の末端と結合した第2の骨ブロックを含む、請求項1記載の骨−腱−骨移植片。The tendon has a first end and a second end, and one or more bone blocks have a first bone block associated with the first end and a second bone associated with the second end The bone-tendon-bone graft of claim 1, comprising a block. 第1の骨ブロックが膝蓋骨に由来し、第2の骨ブロックが脛骨に由来し、腱が膝蓋腱に由来する、請求項10記載の骨−腱−骨移植片。11. The bone-tendon-bone graft of claim 10, wherein the first bone block is from a patella, the second bone block is from a tibia, and the tendon is from a patella tendon. 第1の骨栓および第2の骨栓が連続し、かつ該第1の骨栓または該第2の骨栓の切り出しによって後に切り出される方の骨栓に溝が形成されるように重複している、複数の骨−腱−骨移植片を入手する方法であって、以下の段階を含む方法:
a)腱が結合した第1の骨栓(bone plug)を骨から切り出す段階;および
b)腱が結合した第2の骨栓を該骨から切り出す段階。
The first bone plug and the second bone plug are continuous and overlap so that a groove is formed in the bone plug that is cut out later by cutting out the first bone plug or the second bone plug. A method of obtaining a plurality of bone-tendon-bone grafts, comprising the steps of:
a) severing a first bone plug with attached tendon from the bone; and b) severing a second bone plug with attached tendon from the bone.
切り出しがコアカッターまたは穿孔器によって達成される、請求項12記載の方法。13. The method of claim 12, wherein the cutting is accomplished by a core cutter or a punch. 骨が、膝蓋骨、大腿骨、踵骨および脛骨からなる群より選択される、請求項12記載の方法。13. The method of claim 12, wherein the bone is selected from the group consisting of patella, femur, calcaneus, and tibia. 1つまたは複数の骨ブロックの少なくとも1つが固定ねじを収容するのに適した溝を有する、ヒトまたは動物に対して整形外科手術を行う方法であって、
2つの末端を有する腱および該腱と結合した1つまたは複数の骨ブロックを含む、骨−腱−骨移植片を入手する段階を含む方法。
A method of performing orthopedic surgery on a human or animal, wherein at least one of the one or more bone blocks has a groove suitable for receiving a fixation screw,
A method comprising obtaining a bone-tendon-bone graft comprising a tendon having two ends and one or more bone blocks associated with the tendon.
1つまたは複数の骨ブロックを上記動物の1つまたは複数の骨に固定する段階をさらに含む、請求項15記載の方法。16. The method of claim 15, further comprising the step of securing one or more bone blocks to one or more bones of the animal. 上記動物の1つまたは複数の骨が、膝蓋骨、大腿骨、踵骨および脛骨からなる群より選択される、請求項16記載の方法。17. The method of claim 16, wherein the one or more bones of the animal are selected from the group consisting of patella, femur, calcaneus, and tibia. 1つまたは複数の骨ブロックがダボとしてあらかじめ成形されている、請求項15記載の方法。16. The method of claim 15, wherein the one or more bone blocks are pre-formed as dowels. 1つまたは複数の骨ブロックの直径のサイズが、8mm、9mm、10mm、11mmおよび12mmからなる群より選択される、請求項17記載の方法。18. The method according to claim 17, wherein the size of the diameter of the one or more bone blocks is selected from the group consisting of 8mm, 9mm, 10mm, 11mm and 12mm. 1つまたは複数の骨ブロックがサイズの異なる2つの骨ブロックを含む、請求項18記載の方法。19. The method of claim 18, wherein the one or more bone blocks comprises two bone blocks of different sizes. 1つまたは複数の骨ブロックの少なくとも1つが先細になっている、ヒトまたは動物に対して整形外科手術を行う方法であって、
2つの末端を有する腱および該腱と結合した1つまたは複数の骨ブロックを含む、骨−腱−骨移植片を入手する段階を含む方法。
A method of performing orthopedic surgery on a human or animal, wherein at least one of the one or more bone blocks is tapered,
A method comprising obtaining a bone-tendon-bone graft comprising a tendon having two ends and one or more bone blocks associated with the tendon.
骨−腱−骨移植片が1つの骨ブロックを含み、腱がドナーのアキレス腱、膝蓋腱または四頭筋腱に由来する、請求項21記載の方法。22. The method of claim 21, wherein the bone-tendon-bone graft comprises one bone block and the tendon is from a donor's Achilles, patella or quadriceps tendon. 1つの骨ブロックが第1の末端および第2の末端を含み、該第1および第2の末端が先細になっている、請求項22記載の方法。23. The method of claim 22, wherein one bone block includes a first end and a second end, wherein the first and second ends are tapered. 1つの骨ブロックが少なくとも1つの移植片操作穴を含む、請求項22記載の方法。23. The method of claim 22, wherein one bone block includes at least one implant manipulation hole. 1つの骨ブロックが締り嵌め(interference)ねじを収容するのに充分な溝を含む、請求項22記載の方法。23. The method of claim 22, wherein one bone block includes a groove sufficient to accommodate an interference screw. 整形外科手術が前十字靱帯または後十字靱帯の修復または置換である、請求項21記載の方法。22. The method of claim 21, wherein the orthopedic surgery is a repair or replacement of the anterior or posterior cruciate ligament. 請求項12記載の方法によって作製される骨−腱−骨移植片。13. A bone-tendon-bone graft made by the method of claim 12. 1つまたは複数の骨ブロックおよび該1つまたは複数の骨ブロックと結合した腱を含み、該1つまたは複数の骨ブロックの少なくとも1つが先細になっている、整形外科手術において有用な骨−腱−骨移植片。Bone-tendon useful in orthopedic surgery, comprising one or more bone blocks and a tendon associated with the one or more bone blocks, wherein at least one of the one or more bone blocks is tapered -Bone grafts. 腱が第1の末端および第2の末端を有し、1つまたは複数の骨ブロックが該第1の末端と結合した第1の骨ブロックおよび該第2の末端と結合した第2の骨ブロックを含む、請求項28記載の骨−腱−骨移植片。A tendon has a first end and a second end, one or more bone blocks associated with the first end and a second bone block associated with the second end 29. The bone-tendon-bone graft of claim 28, comprising: 第1の骨ブロックおよび第2の骨ブロックが腱と連続した第1の末端および該第1の末端の反対にある第2の末端を有し、該第1の骨ブロックが第1の末端に向かって先細となり、該第2の骨ブロックが該第2の末端に向かって先細となっている、請求項29記載の骨−腱−骨移植片。A first bone block and a second bone block have a first end contiguous with the tendon and a second end opposite the first end, wherein the first bone block is at a first end. 30. The bone-tendon-bone graft of claim 29, wherein the bone taper tapers and the second bone block tapers toward the second end. 第1の骨ブロックおよび第2の骨ブロックがそれぞれ、固定ねじを収容するのに充分な溝を有する、請求項30記載の骨−腱−骨移植片。31. The bone-tendon-bone graft of claim 30, wherein the first bone block and the second bone block each have sufficient grooves to receive fixation screws. 第1の末端が軸部分と連続し、第2の末端に歯が配置され、円筒が少なくとも1つの長穴(slot)を含む、軸部分ならびに第1の末端および第2の末端を有する円筒部分を含む、骨−腱−骨移植片の摘出に有用な装置。A cylindrical portion having a shaft portion and a first end and a second end, wherein the first end is continuous with the shaft portion, the teeth are disposed at the second end, and the cylinder includes at least one slot. A device useful for the removal of bone-tendon-bone grafts. 歯の半径が約20mm〜約30mmである、請求項32記載の装置。33. The device of claim 32, wherein the tooth radius is between about 20mm and about 30mm. 上記半径が約25mmである、請求項33記載の装置。34. The device of claim 33, wherein said radius is about 25mm. 歯のすくい角(rake angle)が約10度〜約20度である、請求項32記載の装置。33. The device of claim 32, wherein the rake angle of the teeth is between about 10 degrees and about 20 degrees. 上記すくい角が約15度である、請求項35記載の装置。36. The apparatus of claim 35, wherein said rake angle is about 15 degrees.
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